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NCT04021069 Clinical Trial

Using Clinicopathomic Markers to Predict Neoadjuvant Chemotherapy Response in Breast Cancer

Breast Cancer Clinical Trial

Official title:
Using Clinicopathomic Markers to Predict Neoadjuvant Chemotherapy Response in Breast Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04021069
Other study ID # 270-2018
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date August 30, 2018
Est. completion date August 30, 2024

Study information
Verified date July 2019
Source Sunnybrook Health Sciences Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study examines retrospective clinical data on patients diagnosed with breast cancer and monitor their response to neoadjuvant chemotherapy, incidence of locoregional recurrence, distant metastasis, and disease-free survival. The hypothesis of this study is that breast cancer patients who achieve a pathological complete response (pCR) to neoadjuvant chemotherapy demonstrate distinct clinicopathomic biomarker signatures.

Description:

The specific aims of the study are to (1) to identify clinicopathomic biomarkers from pre-treatment core biopsies that are predictive of response to neoadjuvant chemotherapy, (2) determine patterns of metastasis from primary breast cancer to other distant sites, (3) determine the rates of local recurrence in breast cancer patients, and (4) to determine if there are significant radiomic, pathomic, and clinical markers for recurrence and distant metastasis.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 800
Est. completion date August 30, 2024
Est. primary completion date December 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Participants must be men and women age 18+

- Biopsy-confirmed diagnosis of invasive breast cancer; (ER+/-, PR+/-, HER2+/-)

- Any state of disease as described by AJCC v7 criteria

- Participants must have received and completed neoadjuvant chemotherapy

Exclusion Criteria:

- Participants who had other primary cancers prior to breast cancer

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Radiomic, pathomic, and clinical markers
This is a non-interventional study.

Locations
Country Name City State
Canada Sunnybrook Health Sciences Centre Toronto Ontario

Sponsors (1)
Lead Sponsor Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pathologic complete response (pCR) Evaluating the degree of absence of residual cancer cells Up to 60 months
Secondary Time to local breast recurrence Evaluating the time until a recurrence event has occurred in the breast Up to 60 months
Secondary Time to distant metastasis (months) Evaluating onset of distant metastasis Up to 60 months
Secondary Time to death Evaluating time to cancer-related death Up to 60 months
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